Australia Upholds Patent Eligibility Of Isolated DNA

Thanks to Adam Denley, Ph.D., Senior Associate at Freehills Patent Attorneys in Australia, for alerting me to the September 5, 2014 decision of the Full Federal Court of Australia upholding the patent eligibility of isolated nucleic acids, and for letting me share his initial summary here.

Isolated Nucleic Acids Are Patentable In Australia, Again

The Full Federal Court of Australia affirmed that isolated nucleic acids, i.e. whether it be DNA or RNA, are patentable subject matter in Australia. While an appeal to the High Court of Australia may be possible, absent an appeal, isolated nucleic acids will remain patentable subject matter, unless it is excluded by an amendment to the Patents Act. Presently we are unaware of a proposal to amend the legislation on this point.

Consistent with previous principles derived from Australian case law, the Full Federal Court held that the claimed isolated nucleic acid, including cDNA, resulted in an artificially created state of affairs for economic benefit thereby being proper subject matter of a patent. By being removed from the genome and the cell (in other words removed from the natural environment and from the cellular components that enable it to function in vivo) the Court held that the claimed isolated nucleic acid is itself an artificially created state of affairs.

The decision is clear in distinguishing the relevant considerations for patentability in Australia with those adopted by the US Supreme Court which have been, more recently, interpreted by the USPTO. The Full Federal Court rejected the US Supreme Court’s emphasis on the similarity of the ‘location and order of the nucleotides’ of the claimed isolated nucleic acid and that existing within the nucleic acid in nature. Instead the Court was of the view that, even without a change in nucleotide sequence, the claimed isolated nucleic acid was chemically, structurally and functionally different to what occurs in nature.

This decision means the Australian Patent Office will continue to allow patent applicants to claim genetic material, provided the claimed material is qualified as having been “isolated”, or words to that effect.

International Patent Strategies

As different countries take different stands on patent eligibility issues (from isolated DNA to business methods), patent practitioners will need to keep track of what can be patented where in order to develop international patent strategies. This decision from Australia is a good reminder that just because isolated naturally occurring DNA sequence cannot be patented in the U.S. does not mean that they cannot be patented elsewhere. It also should remind the USPTO’ that it is setting the U.S. apart from most of the rest of the world by applying the Myriad decision broadly.

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Much like the Federal Circuit decisions in Myriad were not the final word on the subject in the United States, neither is the Full Federal Court decision the final word on the subject in Australia. An application to appeal to the High Court of Australia (equivalent of your Supreme Court) will be lodged in due course. If the High Court grants leave to appeal it will be sometime before the judicial debate in Australia will be settled law.